Urination is a process by which a human naturally expels urine from the body that contains byproduct of cellular metabolism rich in nitrogen that require elimination from the bloodstream. Urine principally contains water, but also includes an assortment of inorganic salts and organic compounds, including proteins, hormones, and a wide range of metabolites that vary by what was put into the body. Urination represents the primary method for excreting these water-soluble chemicals from the body.
These chemicals, along with the presence of unwanted bacteria, can be detected and analyzed by urinalysis. Doctors order urine tests for patients to make sure that the kidneys and certain other organs are functioning properly, or when they suspect that the patient might have an infection in the kidneys, bladder, or other parts of the urinary tract. The kidneys make urine as they filter wastes from the bloodstream, while leaving substances in the blood needed by the body like proteins and glucose. But if the urine contains glucose, too much protein, or has other irregularities, it may constitute a sign of a health problem or disease.
A urinalysis test can measure the number and variety of red and white blood cells, the presence of bacteria and other organisms, the presence of substances like glucose that should not be found in urine, the pH which shows how acidic or basic the urine is, and the concentration of the urine. The doctor or a laboratory will typically place a dipstick in the urine whose patches change color to indicate things like the presence of white or red blood cells or glucose. The doctor or laboratory will also usually examine the urine under a microscope to check for other substances like bacteria that indicate different health conditions.
But, it can be difficult to collect a urine sample from a child or the elderly or disabled patient to analyze. Acute urinary tract infections (“UTI”) are relatively common in children. Children younger than three years of age are not usually toilet trained yet, so a urine sample will typically be collected from their soiled diaper. Children of ages 3-10 years will usually be toilet trained, but they can be embarrassed by or fearful of the process in the doctor's office, and experience difficulty in urinating upon demand. Moreover, children of ages 3-5 years, older children with severe disabilities, and adults who have difficulty seeing, difficulty with dexterity (implied by having issues with walking and grasping), or a mental disability that may preclude full understanding and execution of a task can also have trouble with the mechanics required for urinating a sample directly into a collection container. It is estimated that 44.8 million children, disabled, and elderly persons in the United States may face these challenges in providing urine samples.
Furthermore, the skin surrounding the urinary opening of the male penis and female vagina is normally home to some of the same bacteria that causes infections in the urinary tract. If these bacteria contaminate the urine sample during the collection process, the doctor may be unable to process the sample to determine whether or not there is a true infection in the patient. Thus, the patient will be required in a “clean catch” process to clean and rinse the skin surrounding the urinary opening in the body, then urinate to expel any bacteria-laden urine, then stop momentarily, and finally urinate again the 1-2 ounce sample into the collection container. Catching this urine sample in “mid-stream” can require unusual coordination and manual dexterity for a child, or disabled or elderly patient.
Various devices have been developed and used over time to assist a patient with providing a urine sample. For example, U.S. Pat. No. 3,811,136 issued to Whitney et al. provides a hand-held urine specimen collection container consisting of a funnel screwed into a collection bottle. The urine is collected by the funnel portion and delivered by gravity into the bottle. U.S. Published Application 2004/0003457 filed by Renda constitutes a portable urinal having a funnel positioned on top of a hand-held base container. But both of these devices must be held and manipulated by the patient with the risk of spillage or contamination of the collected urine sample.
U.S. Pat. No. 5,920,916 issued to Norton discloses a rigid, saddle-shaped funnel that can be manually fitted against the female pelvis. Like a bed pan, it collects urine for delivery to a screwed-on collection vessel. But, the urine collected in this vessel must then be transferred to a collection container by the patient or assistant.
Another common type of urine collection device is mounted inside a toilet bowl. A patient can simply urinate into the toilet in a normal fashion, and the urine sample will fall into some type of container. This type of toilet-mounted urine collection container comes in various designs. For example, U.S. Pat. No. 3,571,817 issued to Gosnell discloses a urine collection bag mounted to the rim of the toilet bowl with the bag suspended into the bowl. The urine must be manually transferred from the bag to another container. U.S. Pat. No. 8,079,562 issued to Denmar discloses a stand-alone urine collection container set onto a bracket mounted onto the toilet bowl. However, the patient must be able to direct the urine flow directly into the container, which can be difficult for female and child patients. U.S. Pat. No. 6,811,754 issued to House, and U.S. Published Application 2004/0241052 filed by House show urine collection cups mounted into the bottom of a rigid collection vessel. U.S. Pat. No. 6,775,852 issued to Alvarez et al. illustrates a urine collection cup held by a flexible bag that is set into the toilet bowl with an elastomeric band at its top secured around the toilet bowl. In all of these cases, the cup will be splashed with urine, and therefore unpleasant for the doctor's assistant to handle.
U.S. Pat. No. 6,358,477 issued to Webb et al. illustrates another design for a “funnel” made from a flexible sheet that is attached to the toilet seat with a collection cup secured to the sheeting by adhesive. U.S. Pat. No. 6,212,698 issued to Stingley et al. discloses a flexible mounting strip positioned on top of the toilet bowl rim. A collection cup is suspended from the bottom of the bag. Once again, the collection cup will be splashed with urine.
U.S. Pat. No. 6,151,972 issued to Venter et al. teaches a rigid molded plastic trough that is clipped to the toilet bowl rim, and suspends a collection cup from its bottom. U.S. Pat. No. 5,146,637 issued to Bressler et al. discloses a rigid plastic funnel that specifically fits into the opening of the toilet bowl with a collection cup suspended from an opening in its bottom.
But, all of these funnel-like devices mounted to toilet bowls suffer from a number of disadvantages. They require complicated mounting rods or brackets that must be manipulated to secure the device to and remove it from the toilet. A flexible sheeting may tear, thereby losing the urine sample into the toilet bowl. A simple cup set onto a mounting bracket may fail to catch the urine sample. The collection cup may be splattered by urine and therefore messy to handle. The urine collected in the cup can become contaminated by bacteria, thereby interfering with the validity of the urinalysis results.
Moreover, none of these urine collection devices used in the medical industry allow for the patient to practice the accepted “clean catch” mid-stream collection process for providing a urine sample free of bacteria contamination. The patient must pass the initial short burst of urine into the toilet, get off the toilet while the urine collection contraption is mounted to the toilet bowl, and then get back onto the toilet to provide the urine specimen. The physical coordination and lack of privacy required by such a process will interfere with the collection of urine samples from patients in many cases.
There are some prior art urine collection devices that purport to accommodate the clean-catch mid-stream urine sample collection process. For example, a “Peezy” collection device is disclosed in S. Collier, F. Matjiu, G. Jones, M. Harbor & S. Hopkins, “A Prospective Study Comparing Contamination Rates Between a Novel Mid-Stream Urine Collection Device (Peezy) and a Standard Method in Renal Patients,” J. Clinical Pathology, vol. 0, pp. 1-4 (2013). The Peezy device incorporates a sponge inserted into a funnel mounted to the top of the collection container. The device is placed in a toilet bowl under the perineum of the patient who allows the urine to flow into the funnel. The urine passes through the device, and the cellulose sponge expands as the first 10-15 ml of urine is passed by the patient. The urine is then forced into the sample container. Any overflow from this funnel and container passes into the toilet. But, the bacteria-laden initial urine flow captured by the sponge can contaminate the subsequent mid-stream urine flow that passes through the same sponge. This defeats the purpose of the clean-catch mid-stream urine collection method. Not surprisingly, the researchers discovered that the Peezy device actually increased the rate of the epithelial cells and mixed growths found in the urine samples when compared against the counts found in the samples collected directly by the conventional clean-catch mid-stream collection process.
A Mittstrom mid-stream urine collection device designed by Charlwood entails a corn starch membrane that covers the sample container held suspended in a toilet bowl by a corn starch saddle. When a patient passes urine, the first three seconds of flow is absorbed by the corn starch membrane and dissolves it, thereby allowing the subsequent urine flow to pass directly into the sample container. But, the dissolved, bacteria-laden membrane can contaminate the mid-stream flow to render the urine sample unreliable for diagnostic testing.
The clean-catch midstream device manufactured and sold by JBOL Ltd. of Oxford, England in the United Kingdom employs a mechanical approach in which air released from the sample container mounted to the device forces the initial urine stream to flow up and out of the container, while the subsequent mid-stream urine flows into the container. But, this “channeling feature” still appears to allow the contaminated initial urine flow to contact the mid-stream urine flow or the sample container. Thus, while the process employed by this particular device may be relatively automatic, it can result in a bacterially contaminated urine sample.
U.S. Pat. No. 7,798,907 issued to Piccionelli et al., Renda, and U.S. Published Application 2005/0177937 filed by Kneese et al. disclose various floating targets and heat or moisture-activated materials useful for encouraging young children to learn to use the toilet. But none of the devices provide any kind of functionality for collecting urine samples, especially via the clean catch process.
A urine sample collection device that can be easily mounted to a toilet bowl having a collection vessel for capturing urine from a patient, and an associated sample collection container portion for gathering the urine sample in an assured manner without the need for manual transfer, while maintaining the integrity and purity of the sample would be beneficial. Moreover, the ability to remove the sample collection container with the urine sample inside from the collection vessel without splashed urine deposits or other mess on the container would also be helpful. Furthermore, the urine sample collection device should collect the mid-stream urine sample after automatically diverting the initial bacteria-laden urine to enable the patient to employ the clean-catch method during delivery of urine to avoid introduction of bacteria from around the urinary opening of the patient's body into the sample. Such a device would greatly facilitate the process for obtaining urine samples from children and elderly or physically infirm patients, while enhancing their sense of independence, privacy, and human dignity in not having a medical assistant intrusively present to assist them with the urine sample collection process.